The Last FDA Approvals in 2012 for World Pharma Regulatory Blockbusters (From Dec. 21 to Dec. 31)
On Dec. 31, 2012, the last day of the year, the FDA came through with a rapid-fire approval of Johnson & Johnson's bedaquiline, the first new treatment for drug-resistant tuberculosis in four decades. The approval was based on mid-stage data after J&J ($JNJ) made its case that the urgent need for a new TB therapy warranted an OK ahead of Phase III results. J&J said it will sell the drug as Sirturo, part of a combination therapy that will now be available as a last-ditch treatment for patients who have failed standard remedies. The FDA handed out the accelerated approval based on rules that allow the agency to green-light a therapy on efficacy data based on a surrogate endpoint.
On Dec. 31, 2012, Salix scores FDA approval for HIV-related diarrhea drug Fulyzaq which ended the troublesome condition that there was no FDA-approved therapies for HIV-associated diarrhea. Fulyzaq racked up yet another year-end approval. Fulyzaq is derived from the red sap of the Croton lechleri plant, making this the second botanical drug ever approved by the FDA.
On Dec. 28, 2012, The FDA saved one of its biggest approvals for Pfizer, BMS win blockbuster FDA approval for Eliquis. Eliquis, the clot buster from Bristol-Myers Squibb ( $BMY ) and Pfizer ( $PFE ), garnered the agency's stamp for use in certain patients with atrial fibrillation, a cardiovascular disease . Bristol and Pfizer--which have suffered from generic competition to the big-selling meds and Lipitor, respectively--have now won approval for the most lucrative use of the drug in the world's top healthcare market. The FDA sanctioned the blood thinner for reducing risk of stroke and blood clots in patients with non-valvular atrial fibrillation, saying that the drug shouldn't be used in patients with artificial heart valves or defective heart valves.
On Dec. 24, 2012, Alexza Pharmaceuticals ($ALXA) has won a long-sought approval for an antipsychotic drug called Adasuve from the FDA. Wasting no time, the company plans to push the inhaled med onto the U.S. market early in the first quarter of 2013. U.S. regulators stamped an approval of Alexza's inhaled version of the antipsychotic drug loxapine for adults struck with agitation linked to schizophrenia or bipolar disorder. The approval comes with warnings about serious adverse events such as potentially lethal bronchospasms and increased risk of death in elders with dementia-related psychosis.
On Dec. 24, 2012, the FDA has approved Aegerion's ( $AEGR ) new drug for homozygous familial hypercholesterolemia, clearing a path to begin commercialization as the biotech comes to a major turning point. Lomitapide will now hit the market as Juxtapid featuring a boxed warning about the distinct threat of liver toxicity.
On Dec. 21, 2012, the FDA has stamped an approval on NPS Pharmaceuticals' ($NPSP) Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug and adds to U.S. regulators' impressive tally of more than 30 new drug nods in 2012. The sanctioning of Gattex isn't a big surprise. FDA advisers unanimously endorsed the drug, which helps patients with the syndrome reduce their dependence on IV feeding, for approval in October. And most of them backed the REMS plan from the company to monitor cancer and other risks associated with the therapy.